Lithium Citrate

The mechanism of action of lithium as a mood stabilizing agent is unknown.

• Lithium is a mood stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies (14) ] Maintenance treatment in patients 7 years and older [see Clinical Studies (14) ] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 ) Maintenance treatment in patients 7 years and older ( 1 )ICD-10: F31.9

• Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium citrate products [see Adverse Reactions (6) ]. Known hypersensitivity to any inactive ingredient in the drug product.contraindicated

Recommended starting dosage for adults and pediatric patients over 30 kg ( 2.2 ): Oral Solution: 8mEq lithium (5 mL) three times daily Recommended starting dosage for pediatric patients 20 to 30 kg ( 2.2 ): Oral Solution: 8mEq (5 mL), twice daily Obtain serum lithium concentration assay after 3 days, drawn 12 hours after the last oral dose and regularly until patient is stabilized. Acute Manic or Mixed Episodes (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1.2 mEq/L ( 2.2 ). Maintenance Treatment for Bipolar I Disorder (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1 mEq/L ( 2.2 ). Pre-treatment Screening: Evaluate renal function, vital signs, electrolytes, thyroid function, concurrent medications, and pregnancy status ( 2.1 ). Mild to Moderate Renal Impairment (Cler 30 to 89 mL/min): Start with dosages less than those for patients with normal renal function, titrate slowly with frequent monitoring ( 2.5 ). Severe Renal Impairment (Cler<30mL/min): Avoid use of lithium ( 2.5 ). 2.1 Pre-treatment Screening Before initiating treatment with lithium, renal function, vital signs, serum electrolytes, and thyroid function should be evaluated. Concurrent medications should be assessed, and if the patient is a woman of childbearing potential, pregnancy status and potential should be considered. 2.2 Recommended Dosage See Table 1 for dosage recommendations for acute and maintenance treatment of bipolar I disorder in adult and pediatric patients (7 to 17 years).

Lithium-Induced Polyuria: May develop during initiation of treatment. Increases risk of lithium toxicity. Educate patient to avoid dehydration. Monitor for lithium toxicity and metabolic acidosis. Discontinue lithium or treat with amiloride as a therapeutic agent ( 5.2 ). Hyponatremia: Symptoms are more severe with faster-onset hyponatremia. Dehydration from protracted sweating, diarrhea, or elevated temperatures from infection increases risk of hyponatremia and lithium toxicity. Educate patients on maintaining a normal diet with salt and staying hydrated. Monitor for and treat hyponatremia and lithium toxicity, which may necessitate a temporary reduction or cessation of lithium and infusion of serum sodium ( 5.3 ). Lithium-Induced Chronic Kidney Disease: Associated with structural changes in patients on chronic lithium therapy. Monitor kidney function during treatment with lithium ( 5.4 ). Encephalopathic Syndrome: Increased risk in patients treated with lithium and an antipsychotic. Monitor routinely for changes to cognitive function ( 5.5 ). Hypothyroidism and Hyperthyroidism: Monitor thyroid function regularly ( 5.7 ). Hypercalcemia and Hyperparathyroidism: Associated with long-term lithium use. Monitor serum calcium ( 5.8 ). 5.1 Lithium Toxicity The toxic concentrations for lithium (≥1.5 mEq/L) are close to the therapeutic range (0.8 to 1.2 mEq/L). Some patients abnormally sensitive to the lithium may exhibit toxic signs at serum concentration that are considered within the therapeutic range [see Boxed Warning , Dosage and Administration (2.3) ].

The following adverse reactions are described in greater detail in other sections: Acute Lithium Toxicity [see Warnings and Precautions (5.1) ] Lithium-Induced Polyuria [see Warnings and Precautions (5.2) ] Hyponatremia [see Warnings and Precautions (5.3) ] Lithium-Induced Chronic Kidney Disease [see Warnings and Precautions (5.4) ] Encephalopathic Syndrome [see Warnings and Precautions (5.5) ] Serotonin Syndrome [see Warnings and Precautions (5.6) ] Hypothyroidism or Hyperthyroidism [see Warnings and Precautions (5.7) ] Hypercalcemia and Hyperparathyroidism [see Warnings and Precautions (5.8) ] Unmasking of Brugada Syndrome [see Warnings and Precautions (5.9) ] Pseudotumor Cerebri [see Warnings and Precautions (5.10) ] Common Adverse Reactions: Adult Patients: fine hand tremor, polyuria, mild thirst, nausea, general discomfort during initial treatment ( 6 ) Pediatric Patients (7-17 years): nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/ dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Precision Dose, Inc. by email at druginfo@precisiondose.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Pregnancy: May cause fetal and/or neonatal harm ( 8.1 ) Renal Impairment: Use caution during dose selection, starting with dosages less than those for patients with normal renal function while carefully monitoring for side effects ( 2.5 , 6 ) 8.1 Pregnancy Risk Summary: Lithium may cause harm when administered to a pregnant woman. Early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for Ebstein's anomaly, with first trimester use of lithium. Subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. There are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see Clinical Considerations ]. Published animal developmental and toxicity studies in mice and rats report an increased incidence of fetal mortality, decreased fetal weight, increased fetal skeletal abnormalities, and cleft palate (mouse fetuses only) with oral doses of lithium that produced serum concentrations similar to the human therapeutic range. Other published animal studies report adverse effects on embryonic implantation in rats after lithium administration. Advise pregnant women of the potential risk to a fetus.

Metabolism

Absorption: After oral administration, lithium is reported to be completely absorbed in the upper gastrointestinal tract. Peak serum concentrations (T max ) occur 0.25 to 3 hours after oral administration of immediate release preparations and 2 to 6 hours after sustained-release preparations.

The toxic concentrations for lithium (≥1.5 mEq/L) are close to the therapeutic concentrations [see Warnings and Precautions (5.1 ) ]. At lithium concentrations greater than 3 mEq/L, patients may progress to seizures, coma, and irreversible brain damage. Treatment: For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1 -800-222-1222 or www.poison.org No specific antidote for lithium poisoning is known. Mild symptoms of lithium toxicity can usually be treated by reduction in dose or cessation of the drug. In severe cases of lithium poisoning, the goal of treatment is elimination of this ion from the patient. Administration of gastric lavage should be performed, but use of activated charcoal is not recommended as it does not significantly absorb lithium ions. Hemodialysis is the treatment of choice as it is an effective and rapid means of removing lithium in patients with severe toxicity. As an alternative option, urea, mannitol and aminophylline can induce a significant increase in lithium excretion. Appropriate supportive care for the patient should be undertaken.

Recent PubMed references pinned to Lithium Citrate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Kinetic optimization in green metal recovery: Citric acid vs glycine for sustainable Li-ion battery recycling.
  Ecotoxicology and environmental safety · 2025 · Zhang Y, Wang Y, Han Z, et al.
  PMID 40716346DOI 10.1016/j.ecoenv.2025.118746
• Environmentally friendly and economic method for recovery of metals from spent lithium-ion batteries using ethylenediaminetetraacetic acid disodium salt and citric acid.
  Waste management (New York, N.Y.) · 2025 · Ali-Zada Z, Şengil IA, Alp A, et al.
  PMID 40435849DOI 10.1016/j.wasman.2025.114896
• Optimization of leaching of lithium and cobalt from spent lithium-ion batteries by the choline chloride-citric acid/malonic acid DES using response surface methodology.
  Environmental research · 2025 · Panda P, Mishra S
  PMID 39848519DOI 10.1016/j.envres.2025.120917
• Enhanced reducing capacity of citric acid for lithium-ion battery recycling under microwave-assisted leaching.
  Waste management (New York, N.Y.) · 2024 · Li S, Zhang W, Xia Y, et al.
  PMID 39146601DOI 10.1016/j.wasman.2024.08.004
• Closed-loop recycling of lithium iron phosphate cathodic powders via citric acid leaching.
  Environmental science and pollution research international · 2025 · Bruno M, Francia C, Fiore S, et al.
  PMID 38468005DOI 10.1007/s11356-024-32837-6
• Preanalytical Quality Evaluation of Citrate Evacuated Blood Collection Tubes-Ultraviolet Molecular Absorption Spectrometry Confronted with Ion Chromatography.
  Molecules (Basel, Switzerland) · 2023 · Gros N, Stopar T
  PMID 38067465DOI 10.3390/molecules28237735
• Recycling of All-Solid-State Li-ion Batteries: A Case Study of the Separation of Individual Components Within a System Composed of LTO, LLZTO and NMC.
  ChemSusChem · 2023 · Waidha AI, Salihovic A, Jacob M, et al.
  PMID 37029553DOI 10.1002/cssc.202202361
• α-Cyano-4-hydroxycinnamic Acid and Tri-Potassium Citrate Salt Pre-Coated Silicon Nanopost Array Provides Enhanced Lipid Detection for High Spatial Resolution MALDI Imaging Mass Spectrometry.
  Analytical chemistry · 2021 · Dufresne M, Fincher JA, Patterson NH, et al.
  PMID 34449196DOI 10.1021/acs.analchem.1c01560

The 10 most recently updated of 452 ClinicalTrials.gov registrations naming Lithium Citrate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
  Recruiting · Observational · 2,350 enrolled · National Institute of Mental Health (NIMH)
  NCT00025935updated 2026-06-12
• A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
  Recruiting · Phase 3 · Interventional · 424 enrolled · Bristol-Myers Squibb
  NCT07140913updated 2026-06-10
• Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants
  Not yet recruiting · Interventional · 40 enrolled · Institute of Tropical Medicine, Belgium
  NCT07636551updated 2026-06-09
• Pharmacokinetic Study of Pembrolizumab and Its Impact on Immunity and the Tumor Microenvironment, Which May Explain the Efficacy of Post-immunotherapy Chemotherapy.
  Not yet recruiting · Phase 4 · Interventional · 110 enrolled · Centre Antoine Lacassagne
  NCT07633613updated 2026-06-08
• LiO-AD: Lithium Orotate in Alzheimers Disease Feasibility, Biomarker Engagement, and Clinical Response
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 40 enrolled · Johns Hopkins University
  NCT07459959updated 2026-06-08
• C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia
  Completed · Interventional · 300 enrolled · Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
  NCT07587164updated 2026-06-03
• A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
  Recruiting · Phase 3 · Interventional · 450 enrolled · Bristol-Myers Squibb
  NCT06929273updated 2026-06-02
• A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
  Recruiting · Interventional · 396 enrolled · University of Greifswald
  NCT04996433updated 2026-05-26
• Validation of the French Version of the Lithium Knowledge Test (LKT)
  Terminated · Observational · 22 enrolled · University Hospital, Lille
  NCT06033326updated 2026-05-22
• A Study Evaluating 24 Months of Lithium Carbonate Treatment in Patients With TBR1-related Neurocognitive Disorder
  Recruiting · Phase 1 · Phase 2 · Interventional · 12 enrolled · Centre Hospitalier Universitaire Dijon
  NCT06776848updated 2026-05-22

Frequently asked questions

How does Lithium Citrate work?

The mechanism of action of lithium as a mood stabilizing agent is unknown.

What is Lithium Citrate used for?

According to FDA labeling, Lithium Citrate carries indications including: Lithium is a mood stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies (14) ] Maintenance treatment in patients 7 years and older [see Clinical Studies (14) ] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 ) Maintenance treatment in patients 7 years and older ( 1 ). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Lithium Citrate?

Lithium Citrate is classified as Norepinephrine Transporter Interactions, Serotonin Transporter Interactions, Norepinephrine Activity Alteration, Serotonin Activity Alteration.

What are the contraindications for Lithium Citrate?

Lithium Citrate labeling lists contraindications including: Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium citrate products [see Adverse Reactions (6) ]. Known hypersensitivity to any inactive ingredient in the drug product.. Always consult the full prescribing information and a clinician.